A Clinical Efficacy Study of Mazdutide in the Treatment of Polycystic Ovary Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• BMI≥28kg/M2

• No plan for pregnancy in the coming 8 months after enrollment

• Patients should meet at least two of the three criteria according to the 2023 international evidence-based guideline for PCOS :

‣ Irregular cycles and ovulatory dysfunction: \< 21 or \> 35 days or \< 8 cycles per year; \> 90 days for any one cycle

⁃ Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter\<10mm), confirmed by ultrasound

⁃ Biochemical hyperandrogenism: total testosterone\>1.67 nmol/L or clinical hyperandrogenism: modified Ferriman Gallwey score (mFG)\>4

Locations
Other Locations
China
Zhongshan Hospital Fudan University
RECRUITING
Shanghai
Contact Information
Primary
LIANGSHAN MU, MD, PhD
mu.liangshan@zs-hospital.sh.cn
02164041990
Backup
JINGJING JIANG, MD, PhD
jiang.jingjing@zs-hospital.sh.cn
02164041990
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 50
Treatments
Experimental: Mazdutide Treatment Arm
Subcutaneous injection of Mazdutide once weekly for 24 weeks.
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov